A Phase 1 interventional study of Estriol 0.125 mg/day and Estriol 0.250 mg/day in Menopause, sponsored by Galeno Desenvolvimento de Pesquisas Clínicas. Completed at 1 site in Brazil. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Galeno Desenvolvimento de Pesquisas Clínicas · Phase 1, Interventional, and Treatment
This clinical trial evaluated the pharmacokinetics and pharmacodynamics of estriol in healthy post-menopausal women after the application of one vaginal ring containing one of three different dosages of estriol (100 mg (Test 1), 300 mg (Test 2) or 600 mg (Test 3)) with continuous delivery (0.125, 0.250 or 0.500 mg/day) for 21 days. And also, characterized its safety and tolerability.
This phase I, single center, open-label, randomised (allocation to treatment), balanced, single dose trial was performed in a parallel-group design. The subjects were randomly assigned to one of the 3 possible treatments (single vaginal application of 1 vaginal ring containing 100, 300 or 600 mg estriol, with delivery rate of 0.125, 0.250 or 0.500 mg/day over 21 days.
Blood samples were collected at 0.5 h prior to drug application, 1, 2, 4, 6, 12, 24, 48, 96, 144, 216, 288, 360, 432 h after application; 5 min prior to removal, i.e., 21 d after application (study day 22), as well as 6, 12 and 24 h after removal to characterise pharmacokinetic parameters of estriol in plasma.
Serum concentrations of follicle stimulating hormone (FSH), luteinising hormone (LH) and sex hormone binding globulin (SHBG) and gynaecological parameters (cytology of vaginal smear, the maturation index and the vaginal pH) were evaluated as pharmacodynamic parameters.
The safety and tolerability was assessed by endometrial thickness and documentation of adverse events.
Galeno Desenvolvimento de Pesquisas Clínicas is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single vaginal application of 1 vaginal ring containing 100 mg estriol, with delivery rate of 0.125 mg/day over 21 days
Drug: Estriol 0.125 mg/day
Single vaginal application of 1 vaginal ring containing 300 mg estriol, with delivery rate of 0.250 mg/day over 21 days
Drug: Estriol 0.250 mg/day
Single vaginal application of 1 vaginal ring containing 600 mg estriol, with delivery rate of 0.500 mg/day over 21 days
Drug: Estriol 0.500 mg/day
Measurement of estriol plasma levels
Blood sampling for the determination of plasma levels of estriol in participants of each treatment group.
Time frame: 0-22 days
Maximum Plasma Concentration (Cmax) of estriol
Determination of Cmax for estriol based on plasma concentrations of samples obtained.
Time frame: 0-22 days
Area Under the Curve (AUC) for estriol
Calculation of the AUC for estriol based on plasma concentrations of samples obtained.
Time frame: 0-22 days
Characterisation of follicle stimulating hormone (FSH)
Determination of serum concentrations of FSH under the three treatments
Time frame: 0-22 days
Characterisation of luteinising hormone (LH)
Determination of serum concentrations of LH under the three treatments
Time frame: 0-22 days
Characterisation of sex hormone binding globulin (SHBG)
Determination of serum concentrations of SHBG under the three treatments
Time frame: 0-22 days
Characterisation of cytology of vaginal smear
Characterisation of cytology of vaginal smear (parabasal, intermediate and superficial cells) under the three treatments
Time frame: 0-22 days
Calculation of maturation index
Calculation of maturation index under the three treatments
Time frame: 0-22 days
Determination of vaginal pH
Determination of vaginal pH under the three treatments
Time frame: 0-22 days
Number of adverse events per participant
Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results.
Time frame: up to 22days after treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Dec 2016, 2 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estriol
Galeno Desenvolvimento de Pesquisas Clínicas